A TISSUE OXYGEN MONITOR

该研究计划是为了继续开发和评估一种微型、机械坚固、简单、廉价、微创的电化学氧传感器。它用于重建手术后植入皮瓣或游离肌肉移植中，并将监测氧气长达五天。外鞘控制传感器的运行环境，膜排除会污染电极的大分子。测量周期的设计是为了避免较小物种的干扰。预计会影响设备精度或稳定性的尺寸和工艺将进行系统评估，并确定最终工艺和材料规格及公差。将设计和制造特殊的工具和设备，以提高重复性并降低制造成本。将开发筛选方法，以拒绝有缺陷的部件，并就提高产量的工艺提供反馈。设备将在实验室中进行广泛的准确性、稳定性和响应时间测试。评估方案将包括灭菌和储存。短期性能将在主动控制血液供应的兔组织瓣中进行评估。长期稳定性将在带皮瓣或游离组织移植的兔身上进行评估。所有动物研究都将在完整或较少受干扰的组织中包括第二个传感器。指示的血氧水平将与静脉血氧水平、临床血流灌注不良的指征和转移性坏死的程度进行比较。来自长期动物的组织将对该设备进行不良异物反应检查。拟议的商业应用：该设备将用于在重建手术中直接监测移植后的组织氧合情况，并提供血管凝结的早期预警。它解决了现有设备的局限性，并提供了目前无法获得的临床相关数据。预计它将在美国市场占据相当大的份额，据估计，美国市场的规模为800万美元。

The research plan is for the continued development and evaluation of a miniature, mechanically rugged, simple, inexpensive, minimally invasive, electrochemical oxygen sensor. It is intended for insertion in flap or free muscle transplants after reconstructive surgery and will monitor oxygen for up to five days. An outer sheath controls the operating environment of the sensor and a membrane excludes large molecules that would contaminate the electrodes. The measurement cycle is designed to avoid interference from smaller species. Dimensions and processes expected to affect the accuracy or stability of the device will be systematically evaluated and final process and material specifications and tolerances established. Special tooling and equipment will be designed and built to improve reproducibility and reduce fabrication costs. Screening methods will be developed to reject defective components and to provide feedback on processes for improved yields. Devices will be tested extensively in the laboratory for accuracy, stability, and response time. Evaluation protocols will include sterilization and storage. Short term performance will be evaluated in rabbit tissue flaps with active manipulation of blood supply. Long term stability will be evaluated in rabbits with flaps or free tissue transfers. All animal studies will include a second sensor in intact or less disturbed tissue. Indicated oxygen level will be compared with venous oxygen levels, clinical indications of poor perfusion, and degree of transfer necrosis. Tissue from the long term animals will examined for adverse foreign body reactions to the device. PROPOSED COMMERCIAL APPLICATIONS: The device will be used to permit direct monitoring of tissue oxygenation after grafting during reconstructive surgery and provide early warning of clotting of blood vessels. It addresses limitations of existing devices and provides clinically relevant data not presently available. It is expected to capture a significant portion of a market estimated at $8,000,000 in the US.